BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 3102812 · Received May 9, 2013

    Report

    Report Number
    3008500478-2013-00425
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION INTO ROOT CAUSE IS ANTICIPATED UPON PRODUCT RETURNED FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETAINED BY THE HOSPITAL AS INITIALLY PERCEIVED. EDWARDS IS UNABLE TO EVALUATE THE DEVICE INTO ROOT CAUSE. THE DEVICE WAS DISCARDED AT THE HOSPITAL. THE EVENT WAS PRESENTED BY THE EDWARDS SALES TEAM AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. INJURIES SUCH AS A HEMATOMA AT THE INSERTION SITE IS LISTED AS A POTENTIAL COMPLICATION IN THE PRODUCT IFU. THE IFU FURTHER NOTES: ENSURE THAT THE INTRODUCER SHEATH TIP IS INSERTED INTRAVASCULARLY.¿ ¿PROPER SURGICAL PROCEDURES AND TECHNIQUES ARE THE RESPONSIBILITY OF THE MEDICAL PROFESSION. DESCRIBED PROCEDURES ARE PROVIDED FOR INFORMATIONAL PURPOSES ONLY. EACH PHYSICIAN MUST DETERMINE THE APPROPRIATE USE OF THIS DEVICE FOR EACH PATIENT BASED ON MEDICAL TRAINING, EXPERIENCE, THE TYPE OF PROCEDURE EMPLOYED, AND THE BENEFITS AND RISKS ASSOCIATED WITH DEVICE USE.¿ ¿CAUTION: TO AVOID POSSIBLE VESSEL WALL PERFORATION, DO NOT LEAVE THE DILATOR IN PLACE AS AN INDWELLING CATHETER.¿ NO DEVICE MALFUNCTION IS INDICTED IN THE REPORT AND THE EVENTS REPORTED ARE INCLUDED IN THE LABELING. NO ACTIONS ARE NEEDED AT THIS TIME. FOR COMPLAINTS/REPORTS OF INJURY WITHOUT A PRODUCT PROBLEM, IT¿S IMPORTANT TO SHOW THAT THE TYPE OF EVENT IS A KNOWN POTENTIAL COMPLICATION OR ADVERSE EVENT, IS INCLUDED IN THE LABELING/TRAINING MATERIALS, AND IN THE INFORMATION WE PROVIDE TO HELP AVOID THE ISSUE. ALL LABELING AND TRAINING APPROPRIATELY ADDRESS THE RISK. MANUFACTURING RECORDS WERE REVIEWED AND FOUND ACCEPTABLE. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE USE OF EDWARDS QUALITY SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICAL SPECIALIST THAT THERE WAS A "HEMATOMA AT SITE OF PR9, PROPLEGE CORONARY SINUS CATHETER'S INTRODUCER. THE HEMATOMA DID NOT INTERFERE WITH THE PLACEMENT. AFTER THE DEVICE WAS PLACED, AND WHILE PREPPING THE PATIENT, THE ANESTHESIOLOGIST AND SURGEON DECIDED NOT TO CONTINUE WITH THE SURGICAL PROCEDURE. THE SURGEON DECIDED TO DO AN EXPLORATORY PROCEDURE IN THE NECK AND TO PULL THE SHEATH UNDER DIRECT SUPERVISION. THE SURGEON DIDN'T FIND ANYTHING UNUSUAL DURING THE NECK EXPLORATION. HE SAID IT WAS A GOOD STICK AND JUST THOUGHT IT WAS BLEEDING AROUND THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203493 PROPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59459900

    Patients

    Seq Age Sex Outcome Treatment
    1